Trials Sponsors Conditions Drugs Pricing

Conditions

COPD Healthy

Keywords

Phase ISafety studyAZD9164

Outcome Measures

Primary Outcomes (1)

Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)
Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study

Secondary Outcomes (2)

Pharmacokinetics samples for AZD9164
PK sampling during the residential period and intense PK sampling day 1 and 15 in healthy and day 13 in COPD patients
Investigation of PD effects
Spirometry at screening and during the residential stay

Study Arms (2)

A

EXPERIMENTAL

AZD9164

Drug: AZD9164 Turbuhaler®

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo Turbuhaler®

Interventions

AZD9164 Turbuhaler®Drug

Dry powder for inhalation via Turbuhaler, MAD. Starting dose in healthy volunteers is 400 µg with up to two dose escalations not exceeding AstraZeneca pre-defined exposure limits. The COPD patients will receive a dose of 1000 µg.

Placebo Turbuhaler®Drug

Dry powder for inhalation via Turbuhaler, MAD

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Healthy male and female, age 18-45, COPD patients \> 40 years
Healthy subjects and COPD patients; Provision of signed and dated, written informed consent prior to any study specific procedures

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (2)

Research Site

Linköping, Sweden

Research Site

Luleå, Sweden

Related Publications (1)

Jorup C, Bengtsson T, Strandgarden K, Sjobring U. Transient paradoxical bronchospasm associated with inhalation of the LAMA AZD9164: analysis of two Phase I, randomised, double-blind, placebo-controlled studies. BMC Pulm Med. 2014 Mar 27;14:52. doi: 10.1186/1471-2466-14-52.
PMID: 24669829DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Carin Jorup
AstraZeneca R&D, Lund, Sweden
STUDY DIRECTOR
Aslak Rautio
Quintiles Hermelinen AB
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 20, 2009

Study Start

December 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2010

Actual (reported)

Study Stopped

A Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Subjects and in Patients With Chronic Obstructive Pulmonary Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations